Department of Obstetrics and Gynaecology, Tenon University Hospital, Paris, France.
Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.
Retrospective single-centre series have shown the feasibility of sentinel lymph-node (SLN) identification in endometrial cancer. We did a prospective, multicentre cohort study to assess the detection rate and diagnostic accuracy of the SLN procedure in predicting the pathological pelvic-node status in patients with early stage endometrial cancer.
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-II endometrial cancer had pelvic SLN assessment via cervical dual injection (with technetium and patent blue), and systematic pelvic-node dissection. All lymph nodes were histopathologically examined and SLNs were serial sectioned and examined by immunochemistry. The primary endpoint was estimation of the negative predictive value (NPV) of sentinel-node biopsy per hemipelvis. This is an ongoing study for which recruitment has ended. The study is registered with ClinicalTrials.gov, number NCT00987051.
From July 5, 2007, to Aug 4, 2009, 133 patients were enrolled at nine centres in France. No complications occurred after injection of technetium colloid and no anaphylactic reactions were noted after patent blue injection. No surgical complications were reported during SLN biopsy, including procedures that involved conversion to open surgery. At least one SLN was detected in 111 of the 125 eligible patients. 19 of 111 (17%) had pelvic-lymph-node metastases. Five of 111 patients (5%) had an associated SLN in the para-aortic area. Considering the hemipelvis as the unit of analysis, NPV was 100% (95% CI 95-100) and sensitivity 100% (63-100). Considering the patient as the unit of analysis, three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area), giving an NPV of 97% (95% CI 91-99) and sensitivity of 84% (62-95). All three of these patients had type 2 endometrial cancer. Immunohistochemistry and serial sectioning detected metastases undiagnosed by conventional histology in nine of 111 (8%) patients with detected SLNs, representing nine of the 19 patients (47%) with metastases. SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer.
SLN biopsy with cervical dual labelling could be a trade-off between systematic lymphadenectomy and no dissection at all in patients with endometrial cancer of low or intermediate risk. Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy.
Direction Interrégionale de Recherche Clinique, Ile-de-France, Assistance Publique-Hôpitaux de Paris.
回顾性单中心研究表明，前哨淋巴结（SLN）识别在子宫内膜癌中是可行的。我们进行了一项前瞻性、多中心队列研究，以评估 SLN 程序在预测早期子宫内膜癌患者盆腔淋巴结病理状态方面的检测率和诊断准确性。
国际妇产科联合会（FIGO）I-II 期子宫内膜癌患者通过宫颈双注射（锝和专利蓝）和系统盆腔淋巴结清扫术进行盆腔 SLN 评估。所有淋巴结均进行组织病理学检查，SLN 进行连续切片和免疫化学检查。主要终点是估计每半骨盆的前哨淋巴结活检的阴性预测值（NPV）。这是一项正在进行的研究，现已结束招募。该研究在 ClinicalTrials.gov 注册，编号为 NCT00987051。
从 2007 年 7 月 5 日至 2009 年 8 月 4 日，法国 9 个中心共纳入 133 名患者。锝胶体注射后无并发症发生，专利蓝注射后无过敏反应。SLN 活检过程中未发生任何手术并发症，包括转为开放性手术。在 125 名符合条件的患者中，111 名至少检测到一个 SLN。111 名中有 19 名（17%）盆腔淋巴结转移。111 名患者中有 5 名（5%）在主动脉旁区域有相关的 SLN。考虑到半骨盆为分析单位，NPV 为 100%（95%CI 95-100），敏感性为 100%（63-100）。考虑到患者为分析单位，有 3 名患者的结果为假阴性（2 名患者对侧盆腔区域有转移性淋巴结，1 名患者在主动脉旁区域有转移性淋巴结），NPV 为 97%（95%CI 91-99），敏感性为 84%（62-95）。这 3 名患者均患有 2 型子宫内膜癌。免疫组化和连续切片检测到 111 名检出 SLN 患者中的 9 名（8%）经常规组织学检查未检出的转移，这 9 名患者中有 19 名（47%）有转移。SLN 活检使低危和中危子宫内膜癌患者的分期分别提高了 10%和 15%。
宫颈双标记 SLN 活检可能是低危或中危子宫内膜癌患者在系统淋巴结清扫术和完全不进行淋巴结清扫之间的一种权衡。此外，我们的研究表明，SLN 活检可以提供重要的数据来定制辅助治疗。
巴黎公立医院集团区域临床研究指导。
